Jay

GUDID 00016958041545

The JAY Duo wheelchair cushion features an integrated, contoured solid seat pan with a soft foam and fluid seat cushion.

SUNRISE MEDICAL (US) LLC

Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion Gel-filled chair cushion
Primary Device ID00016958041545
NIH Device Record Key49b9060b-0862-4ce2-9ca4-4ecd87fdb317
Commercial Distribution StatusIn Commercial Distribution
Brand NameJay
Version Model NumberDuo
Company DUNS962525056
Company NameSUNRISE MEDICAL (US) LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100016958041545 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

On-Brand Devices [Jay]

00016958053678The JAY® Ion® is a comfortable skin protection and positioning wheelchair cushion composed of
00016958052435The JAY® J3® wheelchair back product line offers a multitude of width, height, and contour dep
00016958052015The JAY J3 wheelchair cushion provides outstanding stability and optimal pressure distribution f
00016958046212The JAY J2 Plus is a pre-contoured foam bariatric wheelchair cushion that offers a weight capaci
00016958046205The JAY J2 Plus bariatric wheelchair back is a bi-angular backrest specifically designed to addr
00016958043693The JAY Protector is a small, portable wheelchair cushion designed for clients to use when not s
00016958042610The JAY Care wheelchair cushion was designed to accommodate the client with a fixed posterior pe
00016958042603The JAY Care wheelchair back accommodates a client with a fixed kyphotic thoracic spine by provi
00016958042504The JAY J2 Series wheelchair backs are designed to provide posterior and lateral pelvic stabilit
00016958042252The JAY® GS® wheelchair cushion incorporates a highly durable, stable foam base and JAY's prov
00016958041545The JAY Duo wheelchair cushion features an integrated, contoured solid seat pan with a soft foam
00016958040425The JAY Basic wheelchair back was designed to increase sitting tolerance and stability by adding
00016958060461For individuals who require a more complex seating solution, the JAY FIT 2U Back can be used whe
00016958056785The J3 Back now offers a Carbon Fiber shell option for the ultimate in lightweight performance.
00016958056778The JAY Xtreme Active is a lightweight and low profile wheelchair cushion for active performance
00016958056709Combining the high skin protection qualities of the JAY J2 wheelchair cushion with the stability
00016958053579The Jay Easy Back is designed to provide the important benefits of a proper back support for a w
00016958047332JAY® Fit Seating simplifies the world of made-to-order seating by offering a "semi-personalized
00016958047325JAY® Fit Seating simplifies the world of made-to-order seating by offering a "semi-personalized

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.